A Phase I Pharmacokinetic and Pharmacodynamic Study of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (NSC 330507) Via Intravenous Administration in Patients With Advanced Malignancies
- Determine the maximum tolerated dose for a geldanamycin analogue,
17-allylamino-17-demethoxygeldanamycin (AAG), in patients with advanced malignancies.
- Determine the toxic effects and dose-limiting toxicity of AAG in this patient
- Determine the safe dose of AAG for a Phase II study.
- Measure the pharmacokinetic and pharmacodynamic profiles of AAG in these patients.
- Assess time to tumor progression and any antitumor activity in patients treated with
OUTLINE: This is a dose-escalation study.
Patients receive a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), IV
over 15-30 minutes every week. Treatment continues in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
patients experience dose-limiting toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Primary Purpose: Treatment
Recommended phase II dose of 17-allylamino-17-demethoxygeldanamycin (17-AAG) at 4 weeks
Ian R. Judson, MA, MD, FRCP
Royal Marsden NHS Foundation Trust
United States: Federal Government